Cleaning device and methods

ABSTRACT

An apparatus for treating tissue within a lumen may include a therapeutic or diagnostic instrument. A cleaning device may also be supported by the instrument. The cleaning device has a portion of a cleaning surface positioned proximal to the distal end of the cleaning device.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD OF THE INVENTION

Aspects of the invention relate to the removal of tissue between treatment procedures. In one application, embodiments of the present invention provide cleaning devices and methods useful in removing debris from tissue treatments. In other applications, embodiments of the invention provide cleaning devices and methods useful in preparing the tissue or area of a treatment site in advance of treatment by removing mucus, blood and alimentary tract by products such as bile and feces, for example.

BACKGROUND OF THE INVENTION

During ablation procedures to treat various disease states, previously treated tissue in the ablation field can impair subsequent ablation of the same area if the treated tissue remains adherent to the ablation zone. Effectiveness of subsequent ablation will be diminished if treated tissue is still present. To improve the procedure and efficacy of ablation, devices and techniques are needed to remove previously treated tissue prior to subsequent ablation.

SUMMARY OF THE INVENTION

In one aspect, embodiments of the present invention provide an apparatus for treating tissue within a lumen that include a therapeutic or diagnostic instrument and a cleaning device supported by the instrument having a portion of a cleaning surface positioned proximal to the distal end of the cleaning device. In one embodiment, the cleaning device comprises a porous material or a porous material having open cells. In another aspect, a portion of the cleaning device comprises a blunt edge. In one aspect, the blunt edge is supported by one or more of a frame, a ridge or a ring.

In another aspect, the cleaning device is shaped to mount onto the instrument. Additionally, the cleaning device may also include an adhesive surface used to secure the cleaning device to the instrument. There may also be a sheath around at least portion of the cleaning device. In one embodiment, there is provided a chamber in the instrument for cleaning the cleaning device. In some embodiments, the therapeutic or diagnostic instrument is an endoscope. In one aspect, the cleaning device remains in a stowed condition during movement to a treatment site. In another aspect, the cleaning device is movable between a stowed condition adjacent the instrument and a deployed condition for engaging tissue on the lumen. In one aspect, the diameter of the cleaning device in the stowed condition is less than the diameter of the cleaning device in the deployed condition.

In still other embodiments, the cleaning device is formed from a compressible material. The cleaning device may also be formed from a compressible, porous material having at least one blunt edge on the exterior of the device. In one embodiment, there is a cavity in the cleaning device for storing a portion of the tissue from the lumen. In one specific aspect, the cavity is a pore of the cleaning device.

In one specific aspect, the cleaning device is a brush. In another specific aspect, the cleaning device is a balloon. Additionally, the balloon may also include a surface textured for tissue removal. In other additional aspects, the cleaning device is releasably joined to the exterior surface of the instrument. In furtherance of this aspect, the cleaning device is shaped to conform to the outer surface of a portion of the instrument.

In still other aspects, there is provided another cleaning surface on the cleaning device that is non-continuous with the cleaning surface. In one aspect, the cleaning device has a proximal end and a distal end and the proximal end has a circumference that nearly matches the circumference of the instrument and the distal end that has a circumference larger than the instrument. In another aspect, the cleaning surface is positioned on the distal end of the cleaning device and the another cleaning surface is on a tapered surface extending from the distal end of the cleaning device. In some embodiments, there is a recess between the cleaning surface and the another cleaning surface. In an additional aspect, the cleaning surface and the another cleaning surface are rings at least partially extending about the instrument. Additionally, at least one of the rings is helically arranged around the instrument. Alternatively, a compressible element is positioned between the instrument and the rings. The compressible element may include a porous material.

In another aspect, the cleaning surface or the another cleaning surface comprises an edge. In one embodiment, the edge is supported by one or more of a frame, a ridge or a ring. In another aspect, the cleaning device is shaped to mount onto the instrument. Additionally, there may be an elastic mounting component on the cleaning device adapted and configured to secure the cleaning device to the instrument. Additionally, there may be a sheath around at least a portion of the cleaning device that holds the cleaning surface or the another cleaning surface against the instrument. In one aspect, the cleaning device is moveable between a stowed condition where at least one cleaning surface is against the instrument and a deployed condition where at least one cleaning surface extends from the instrument.

In another aspect, at least one of the cleaning surface or the another cleaning surface is on the sidewall of the instrument. Additionally, a cleaning surface is positioned along the longitudinal axis of the cleaning device. Still further, a cleaning surface may be a ring at least partially extending about the instrument. The cleaning device may include a compressible element, a porous material and/or an edge.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which.

FIG. 1 is a flowchart illustrating one method of the invention;

FIG. 2 illustrates the use of a cleaning device within the esophagus;

FIG. 3 illustrates the use of an ablation device within the esophagus;

FIG. 4 illustrates treatment sites created within the esophagus as a result of ablation;

FIG. 5 illustrates a cleaning device positioned at a treatment site;

FIG. 6 illustrates the use of a cleaning device to remove treated tissue from a treatment site;

FIGS. 7A and 7B illustrate perspective and end views, respectively, of an ablation device;

FIGS. 8A and 8B illustrate perspective and end views, respectively, of an ablation device with a cleaning device;

FIGS. 9A, 9B and 9C illustrate perspective, end and cross section views of a cleaning device;

FIGS. 10A, 10B and 10C illustrate alternative cleaning device embodiments;

FIGS. 11A and 11B illustrate a technique to secure a cleaning device to an instrument;

FIG. 12 illustrates the use of an adhesive on the ends of a cleaning device to secure the cleaning device to an instrument;

FIG. 13A illustrates a cleaning device in the form of a sheet with an adhesive backing;

FIG. 13B illustrates the cleaning device of FIG. 13A being applied to an instrument;

FIG. 14 is a perspective view of a cleaning device with a slot to allow attachment to an instrument;

FIG. 15 is a perspective view of a cleaning device positioned on the distal end of an instrument;

FIG. 16 is a perspective view of a cleaning device positioned on the distal end of an instrument;

FIG. 17 is a perspective view of a cleaning device positioned to on the distal end of an instrument;

FIGS. 18A and 18B are perspective and end views, respectively, of a cleaning device positioned on the distal end of an instrument;

FIGS. 19A and 19B are perspective and end views, respectively, of a cleaning device positioned on the distal end of an instrument;

FIGS. 20A and 20B are perspective and end views, respectively, of a cleaning device positioned on the distal end of an instrument;

FIGS. 21A and 21B are perspective and end views, respectively, of a cleaning device positioned on the distal end of an instrument;

FIGS. 22A and 22B are perspective and end views, respectively, of a cleaning device positioned on the distal end of an instrument;

FIG. 23 is a perspective view of a cleaning device positioned on the distal end of an instrument;

FIG. 24 is a perspective view of a cleaning device positioned on the distal end of an instrument;

FIG. 25 illustrates a cleaning device in a stowed configuration within a sheath;

FIG. 26A illustrates a cleaning device within a cavity in an instrument; and

FIG. 26B illustrates the cleaning device of FIG. 26A in use to remove tissue.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a flowchart 100 illustrating one embodiment of method of the invention. First, at step 105, ablate tissue at a treatment site. FIG. 3 illustrates the placement of an ablation device 80 within the esophagus 10 at a treatment site 60. The ablation device 80 may be any device configured to ablate targeted tissue using any suitable ablation technique. Ablation may be achieved through any known technique and using any of the wide variety of energy forms including the non-limiting examples of radiofrequency (RF), IR light, laser, cryogenic, steam, convective heat, microwave and ultrasound. FIG. 4 illustrates a treatment site 60 or sites created within the esophagus 10 as a result of ablation the ablation procedure. After ablation, treated tissue 62 is present at the treatment site 60.

Returning to FIG. 1, next at step 110, attach a cleaning device to an instrument. Numerous alternative cleaning device designs are described below. Alternatively, the cleaning device may be attached to the instrument before the ablation occurs and/or be present while ablation occurs. The instrument may be a shaft of sufficient length to allow the cleaning device to reach a treatment site within the body. The instrument may also be an endoscope or other therapeutic or diagnostic instrument. As used herein, a cleaning device is any device adapted for removing tissue from the treatment site using abrasion, scraping, rubbing, alone or in any combination. A cleaning device may be attached to an instrument permanently, formed as part of a unitary structure or may be removable from the instrument. A cleaning device may be a single use or reusable, with or without sterilization.

FIG. 2 illustrates the placement and use of a cleaning device 370 within the esophagus 10 at a treatment site 60. First, the cleaning device 370 is attached to the distal end of the instrument 50. The instrument 50 is advanced through the mouth (an insertion tube 82 is shown in place in the mouth), past the pharynx 32 and into the esophagus 10.

In some embodiments, while the cleaning device passes any narrowed areas, such as the pharynx or upper esophageal sphincter, the device moves to a smaller size configuration against the instrument. After passing the constriction, the cleaning device expands back to its fully deployed size. In this way, the device is in a deployed condition when the device is finally positioned at the treatment site. The characteristic of moving between a stowed and deployed condition could be a function of the compressible material in the cleaning device as in the embodiments of FIGS. 9A-14. Additionally or alternatively, the characteristic of moving between a stowed and deployed condition could be a function of: the use of malleable scrapers as in FIGS. 18A-24; through the use of a sheath as in FIG. 25; or the use of a stowage chamber or working channel as an FIG. 26A.

The instrument 50 is advanced along the esophagus 10 until the cleaning device 370 is positioned in the desired location within the treatment site 60. FIG. 5 illustrates a close-up view of cleaning device 370 in proximity to the treatment site 60. Visualization of the esophagus and the treatment site are provided by the instrument 50. Returning to FIG. 2, the cleaning device 370 is moved relative to the treatment site 60 by moving the instrument handle 18 as indicated by the arrows 20. Relative movement and contact between the cleaning device 370 and the treatment site 60 results in removal of treated tissue 62 from the treatment site 60 using any of a number of mechanisms alone or in any combination. Relative movement between the cleaning device 370 and the treatment site 60 may be produced by rotating, vibrating, oscillating, or other movement of the cleaning device 370 or a cleaning surface of a cleaning device in relation to the treated tissue 62 at the treatment site 60.

Returning to FIG. 1, next at step 115, remove ablated tissue at the treatment site with the cleaning device. FIG. 6 illustrates the use of a cleaning device 370 to remove treated tissue 62 from a treatment site 60. The initial use of the cleaning device 370 produced the cleaned site 64 where the ablated tissue 62 was removed. Ablated tissue 62 remains at the treatment site 60. The cleaning device 370 and cleaning process continues until the ablated tissue 62 is removed or until the treatment site 60 is adequately prepared for a follow on ablation step, if desired. Once cleaning is completed or sufficiently complete such that ablation may resume, the treatment site 60 returns to the condition illustrated in FIG. 3 where the treatment site 60 is ready for ablation and the ablation device 80 is in position.

Tissue removal may be accomplished through physical contact between a cleaning surface or portion of the cleaning device and the tissue at the treatment site. The cleaning device may be used in conjunction with flushing of the treatment site with liquids or air provided by the instrument. The cleaning device may be manipulated to remove tissue through any of a number of different mechanisms. Embodiments of the cleaning devices of the present invention may remove tissue from a treatment site through abrasion, scraping and/or rubbing. As will be appreciated in the description that follows, one or more cleaning surfaces of a cleaning device may be configured for rubbing, abrasion and/or scraping tissue.

Returning to FIG. 1, next at step 120, determine whether an additional treatment is needed at the treatment site. Based on the individual needs of the patient, multiple ablation steps may be performed in order to accomplish the desired amount of tissue removal. Alternatively, it may be desirable for multiple ablations between cleaning steps. If additional treatment is needed, return to step 105 and ablate tissue at a treatment site. If no additional treatment is needed, the method ends. Steps 105, 110 and 115 may, if desired, be repeated numerous times to provide a method of treatment where by ablated tissue from a previous ablation therapy is removed from a treatment site before a subsequent ablation therapy is provided at the treatment site. It is believed that the intermediate step of removing tissue from a previous ablation step increases the efficiency and efficacy of subsequent ablation steps. Also the uniformity of the tissue (no debris) enables a more controlled and safer ablation.

FIGS. 7A and 7B illustrate perspective and end views, respectively, of an ablation device 150 positioned on the distal end 52 of an instrument 50. The ablation device 150 includes suitable electrical connections including conductive wires 133 to connect the ablation structure 130 to a power source (not shown) as is conventional in the RF ablation arts. The conductive wires 133 can be wrapped or drawn over a distal end of the longitudinal support 114 and pass beneath the support 114. Such an arrangement advantageously facilitates rotational movement of the longitudinal support 114 by preventing binding or restriction of rotational movement. Additionally or alternatively, the ablation device 150 can further include one or more electrode trace 131. The one or more electrode trace 131 can be constructed and arranged to conform to at least a portion of the longitudinal support 114. The one or more trace 131 can be in electrical communication with an electrode 132 and conductive wire 133.

FIG. 7A illustrates the ablation device 150 in position at a treatment site 60 within the esophagus 10 prepared for use in methods for ablating tissue. The ablation structure 132 is rotationally deflectable toward tissue at the target site 60 surface and the ablation structure 132 is activatable to ablate tissue at the target site 60. The ablation structure 132 is supported by an ablation device support structure. The ablation device support structure includes a base 112 with a longitudinal support 114 and a rotational support 116.

As best seen in FIG. 7B, the base 112 can be constructed and arranged in any of a number of ways to support the ablation device 150. In the illustrated embodiment, the base 112 is constructed and arranged to attach the ablation device 150 to an outside surface of the instrument 50, here an endoscope. The base 112 may also be constructed and arranged as a sheath and may also include a connecting element, a band or a strap to further secure the ablation device 150 to the instrument 50. In the illustrated embodiment, the base 112 includes a stop or lip 113 feature. The lip 113 can be constructed and arranged to function as a stop designed to aid in positioning the ablation device 150 in relation to the instrument 50.

The longitudinal support 114 is also constructed and arranged to support the ablation structure 132 in cooperation with the base 112. The support 114 can be made of any suitable material for withstanding the high energy flux produced by the ablation structure 130. The longitudinal support 114 can be flexible, enabling rotation about two axes, thereby further permitting rotation of the longitudinal support 114 away from the longitudinal axis (not shown). In one embodiment the longitudinal support is made of an elastic material, for example, silicone. Other suitable materials include, for example, urethanes or other polymers.

The rotational support 116 is adapted to permit at least a part of the ablation structure 132 to rotate with respect to the longitudinal support's longitudinal axis.

As best seen in FIG. 7A, an actuator mechanism 134 is provided for actively governing the rotation of the longitudinal support 114. Generally the actuator mechanism 134 permits interconversion between a rotationally constrained longitudinal support 114 and free rotation of the support 114. Additional details of various aspects of the construction and operation of ablation devices are described in United States Patent Application Publication US 2007/0118104 titled “Auto-Aligning Ablating Device and Method of Use” commonly assigned to the assignee of the present application and incorporated herein by reference in its entirety.

FIGS. 8A and 8B illustrate perspective and end views, respectively, of the ablation device of FIGS. 7A and 7B with a cleaning device 290 attached. In the illustrated embodiment, the cleaning device 290 is an embodiment of the device illustrated in FIG. 14. The cleaning device 290 has a slot 293 sized to fit over the shaft of an instrument 50. The inner surface of the cleaning device may include an adhesive to affix the cleaning device to the instrument 50. The cleaning device slot 293 may be configured to secure the cleaning device 290 to the instrument 50 with a friction lock. As shown in FIGS. 8A and 8B, the slot 293 is sized to fit onto and secure the cleaning device 290 to the shaft of the instrument 50.

FIGS. 9A, 9B and 9C illustrate perspective, end and cross section views of a cleaning device 200. The cleaning device 200 includes a body 205 having a distal end 210 and a proximal end 220 and an opening 225 on the proximal end sized to fit onto the distal end 52 of an instrument 50. The cleaning device distal end 210 may be closed so that the cleaning device 200 remains on the distal end of the instrument. Alternatively, the cleaning device distal end 210 may be opened so that the cleaning device 200 may be advanced proximal to the distal end 52 of the instrument 50.

The cleaning devices described herein may be formed from any of a wide variety of abrasive materials including compressible and non-compressible materials. For example, the cleaning device 200 may be formed from porous or foam materials including but not limited to: polyurethane esters, polyurethane ethers, micro-cellular urethanes, latex foams, natural sponge rubber, filter foams, conductive foams, melamine polyamide, polyesters, polyethers, polyethylene, chemically cross-linked polyethylene, irradiation cross-linked polyethylene, EVA, neoprene, EPDM, nitrile vinyl, PVC, nylon, silicone, PTFE, EPTFE, open or closed cell forms, reticulated or non-reticulated foam structures, and plasma treated structures to increase material hydrophobicity.

Cleaning devices of the present invention may include one or more cleaning surfaces. The multiple cleaning surfaces provided by the cleaning device 200 are best seen in FIG. 9C. The distal end 210 may include an edge or shaped surface 207. The angled surface proximal to the distal end may provide an additional cleaning surface 209. Another cleaning surface 211 may be provided along the longitudinal axis of the cleaning device body 205. The angled surface distal to the proximal end may provide an additional cleaning surface 213.

FIGS. 10A, 10B and 10C illustrate alternative cleaning device embodiments. FIG. 10A illustrates a cleaning device 230 having a distal cleaning surface 233 including a distal edge 234. The angled cleaning surface 235 proximal to the distal end is less defined than the similar cleaning surface 209 illustrated in the cleaning device 200 of FIG. 9C. Similarly, the angled surface 238 distal to the proximal end is also less defined than the similar cleaning surface 213 illustrated in the cleaning device 200 of FIG. 9C. The cleaning device 230 also includes a longitudinal cleaning surface 237.

FIG. 10B illustrates a cleaning device 240 having a short, blunt body 242. Additionally, the cleaning device 240 has a distal cleaning surface 243 formed by the blunt distal tip of the device. The cleaning device 240 also includes a longitudinal cleaning surface 245.

FIG. 10C illustrates a cleaning device 250 similar to the cleaning device 200. The cleaning device to 50 includes a body 252 shapes to have a rounded tip cleaning surface 253, a distal end cleaning surface 255, a longitudinal cleaning surface 237 and a proximal cleaning surface 238. The cleaning device 250 differs from the cleaning device 200 and in that none of the cleaning surfaces on the cleaning device 250 contain any edges common to the cleaning surfaces of cleaning device 200. Instead, the cleaning device 250 has an elongated shape similar to the cleaning device 200 without the edges. The cleaning surfaces of the cleaning device 250 are less distinct, not well defined and blend one into the next as illustrated in FIG. 10C.

The cleaning device may be affixed to an instrument using any suitable technique. FIGS. 11A and 11B illustrate one technique to secure a cleaning device to an instrument 50. The cleaning device 260 includes a distal cleaning surface 262, a longitudinal cleaning surface 237 and a distal opening 225 sized to fit the instrument 50. As best seen in FIG. 11A, the cleaning device 260 is positioned onto the instrument distal end 52 with an elastic sleeve 291 positioned distal to the cleaning device proximal end. The cleaning device 260 is secured to the instrument 50 by unrolling the elastic sleeve 291 as shown in FIG. 11B.

Alternatively, an adhesive may be used to affix a cleaning device to an instrument. FIG. 12 illustrates a cleaning device 270 with a rolled proximal end 272 and rolled distal end 274. The exposed portion of the rolled ends contacts the instrument outer surface when unrolled. A suitable adhesive 275 is applied to the exposed surface as best seen in FIG. 12. When the rolled ends 272, 274 are unrolled, the adhesive 275 secures the cleaning device 270 to the instrument 50.

The cleaning device need not limited to elongate, cylindrical, or rounded structures. A cleaning device may take any of a variety of shapes. For example, a cleaning device they be a rectangular sheet. FIG. 13A illustrates a cleaning device 280 in the form of a rectangular sheet with an adhesive backing 275. The cleaning device 280 may be formed from an abrasive material or the sheet may be formed from a suitable base material with an abrasive surface or abrasive elements attached thereto. FIG. 13B illustrates the cleaning device 280 of FIG. 13A being applied using the adhesive backing 275 to a position proximal to the instrument distal end 52.

In other embodiments, the cleaning device may be shaped to conform to or attach to the outer surface of the instrument 50. Conforming to the outer surface of the instrument 50 includes conforming to the entire outer surface or only a portion of the outer surface. FIG. 14 is a perspective view of a cleaning device 290 with a c-shaped body 292 having a longitudinal slot 293 to allow attachment to an instrument 50. The cleaning device 290 would partially conform to a suitably sized cylindrical instrument, such as an endoscope for example. The slot 293 allows the cleaning device 290 to snap onto the instrument 50 at any desired position on the instrument (see FIGS. 8A and 8B).

A cleaning surface may also include all or a portion of the outer surface of a cleaning device. The outer surface includes the gross shape of that surface, such as a cylindrical shape for example. The outer surface may also include features on that outer surface such as edges, frames or loops. While the descriptions above for FIGS. 9-14 may refer to edges, sides, or portions of a particular shape of cleaning device, the cleaning surface may also include the cleaning device in its entirety.

FIG. 15 is a perspective view of a cleaning device 310 positioned on the instrument distal end 52. Optionally, a joint or attachment 78 secures the cleaning device 310 to the instrument distal end 52. Alternatively, the cleaning device 310 and the instrument 50 are a single unitary device. The cleaning device 310 includes a distal end 311, a proximal end 309 and an opening 318. The cleaning device 310 includes a number of cleaning surfaces. A portion of the cleaning surface 316 is positioned proximal to the distal end of the cleaning device 311. The cleaning surfaces include, at least, the edge 312, the top surface 316 and outer surface 314. In one embodiment, the cleaning device 310 is a plastic endoscopic mucosal resection cap.

FIG. 16 is a perspective view of a cleaning device 320 positioned on the distal end 52 of an instrument 50. The cleaning device 320 includes a distal end 321 and a proximal end 322. The cleaning device 320 includes a distal angled cleaning surface 323. The cleaning device 320 may be formed from a single spiral band or, alternatively, from a plurality of single rings or bands joined together. In one aspect, FIG. 16 illustrates an edge, here either distal end 321 or angled surface 323, that is supported by one or more of a frame, a ridge or a ring. The spiral shaped bends 324 may also be cut from a tube using techniques similar to those used in the fabrication of stents.

The use of single or multiple bands produces a large number of cleaning surfaces. One cleaning surface is the spiral ring outside surface 324. Another cleaning surface is an edge 326 of the spiral ring. The cleaning surfaces on the cleaning device 320 may be smooth and as illustrated or textured to improve cleaning efficiency.

Cleaning device 320 also illustrates one embodiment of the cleaning device having a cleaning surface such as the distal and 321 and another cleaning surface that is non-continuous with a distal and 321 such as the angled surface 323. Similarly, either the distal and 321 or the angled surface 323 are non-continuous cleaning surfaces with regard to the bend cleaning surfaces 324. In another alternative, all or a portion of the spiral ring could be used to at least partially extend about the instrument.

FIG. 17 is a perspective view of a cleaning device 330 positioned to on the instrument distal end 52. Like the cleaning device of FIG. 16, the cleaning device 330 includes a longitudinally arranged ring 331 with a number of cleaning surfaces. Cleaning surfaces of the ring 331 include edges 334 and surfaces 332. In one aspect, the device 330 is attached to the instrument 50 at both ends. When the distal end of the instrument 50 is straight as illustrated, the ring 331 remains generally aligned along the longitudinal axis of the instrument 50. Because the device 330 is not attached along its length, flexing or bending the instrument distal end 52 causes the ring 331 to flex causing the edges 334 to fan outward to produce a multi-edge scraping structure. The device 330 also illustrates another example of an edge that is supported by one or more of a frame, a ridge or a ring.

FIGS. 18A and 18B are perspective and end views, respectively, of a cleaning device 340 positioned on the instrument distal end 52. The distal end cleaning device 340 includes two cone shaped scrapers namely an outer cone 341 and an inner cone 342. The proximal end 343 of device 340 is adapted to fit onto the instrument 50. The cone scrapers 341, 342 are arranged about the instrument 50 with distal facing openings. Cone 341 terminates in an edge 344. Cone 342 terminates in an edge 345. In other embodiments, the cones 341 and 342 may terminate in multiple edges, textured edges, or combinations thereof. A recess 346 exists between the inner surface of cone 341 and outer surface of cone 342. Recess 346 allows for an area to retain debris produced as a result of cleaning.

FIGS. 19A and 19B are perspective and end views, respectively, of a cleaning device 350 positioned on the instrument distal end 52. The distal end cleaning device 350 includes three cone shaped scrapers namely an outer cone 341, an inner cone 342 and an end cone 347. The proximal end 343 of device 350 is adapted to fit onto the instrument 50. The cone scrapers 341, 342 and 347 are arranged about the instrument 50 with distal facing openings. Cone 341 terminates in an edge 344. Cone 342 terminates in an edge 345. Cone 347 terminates in an edge 348. In other embodiments, the cones 341, 342 and 347 may terminate in multiple edges, textured edges, or combinations thereof. A recess 346 exists between the inner surface of cone 341 and outer surface of cone 342. Recess 346 allows for an area to retain debris produced as a result of cleaning. Similarly, a recess 349 exists between the end cone 347 and the inner cone 342.

FIGS. 18A, 18B, 19A, and 19B illustrate scrapers with a truncated conical shape and a circular distal opening. Other shapes and configurations are possible. The distal openings may have an elliptical, oblong, or other non-circular shapes. In the illustrated embodiments, the cones are concentrically arranged relative to one another or to the instrument 50. Other arrangements are possible. For example, the cones may be arranged eccentrically about the instrument 50.

Moreover, while the previous embodiments illustrate cleaning surfaces that are cones arranged about an instrument, other cleaning surface configurations are possible. For example, a single flap may be used. FIGS. 20A and 20B are perspective and end views, respectively, of a cleaning device 360 positioned on the instrument distal end 52. The cleaning device 360 includes a body 361 and a proximal end 363 configured to engage with or remain on the instrument 50. A single flap 362 extends from the body 361. The flap 362 terminates in a distal edge 344. The flap distal edge 344 extends beyond the instrument distal end 52. The flap 344 also includes a longitudinal edge 366 and a proximal edge 367. As illustrated, the distal edge 344, longitudinal 366 and proximal edges 367 are smooth. In other embodiments, the flap edges may terminate in multiple edges, textured edges, or combinations thereof. As best seen in FIG. 20B, the flap 362 is arranged about the top portion of the instrument 50.

FIGS. 21A and 21B are perspective and end views, respectively, of another cleaning device positioned on the distal end of an instrument having a single flap cleaning surface. The cleaning device 370 includes a body 371 with a proximal and 373 configured to engage with or remain on the instrument 50. A single flap 372 extends from the body 371 beyond the instrument distal end 52. The flap 372 terminates in a distal edge 344. The flap distal edge 344 extends beyond the instrument distal end 52. The flap 372 also includes edge 366 and a tapered longitudinal edge 377. As illustrated, the distal edge 344, tapered longitudinal edge 377 and edge 366 are smooth. In other embodiments, each edge may include multiple edges, be textured, be subjected to surface treatment, or combinations thereof. As best seen in FIG. 21B, the flap 372 is arranged about the top portion of the instrument 50.

FIGS. 22A and 22B are perspective and end views, respectively, of a multiple flap cleaning device 380 positioned on the distal end of an instrument. The cleaning device 380 includes a body 381 and a proximal end 383 configured to engage with or remain on the instrument 50. Three flaps to 62, 382, and 384 extend distally from the body 381. The flap 362, described above in FIG. 21B, terminates in a distal edge 344. The flap 362 distal edge 344 extends beyond the instrument distal end 52. The flap 362 also includes a tapered longitudinal edge and a proximal edge as described above. The flap 382 terminates in a distal edge 344. The flap 382 distal edge 344 extends beyond and above the instrument distal end 52. The flap 382 also includes a tapered longitudinal edge and a proximal edge. The flap 384 terminates in a distal edge 344. The flap 384 distal edge 344 extends beyond and above the instrument distal end 52. The flap 384 also includes a tapered longitudinal edge and a proximal edge. The illustrated edges 344 are smooth. In other embodiments, the flap edges 344 may terminate in multiple edges similar to windshield wiper blades, be textured or roughened, or combinations thereof. As best seen in FIG. 22B, the flaps 362, 382 and 384 are arranged about the instrument distal end 52.

While illustrated as having a proximal end larger than the diameter of the instrument 50, in other embodiments of the cleaning devices in FIGS. 20A-22B, the proximal end of the device is the same diameter so as to form a friction fit on the instrument 50 as illustrated in FIGS. 18A and 19A.

FIG. 23 is a perspective view of a cleaning device 390 positioned on the instrument distal end 52. The cleaning device 390 includes a plurality of cleaning surfaces including surfaces 392 and edges 394. Recesses 396 are formed where an edge 394 extends over a surface 392. The cleaning device 390 may be formed from organic or non-organic polymers whereby the stiffness of the edges controlled by both material selection and dimension, is adequate to achieve scrapping. While illustrated as smooth, the surfaces 392 and edges 394 of the cleaning device 390 may be textured, roughened, or include surface features to increase the cleaning efficiency.

FIG. 24 is a perspective view of a cleaning device 400 positioned on the distal end of an instrument 50. The cleaning device 400 includes a body 402 on the distal end of an instrument. A flap 360, described above in FIG. 20A, is attached to the body 402 and extends beyond the instrument distal end 52. A ring 404 is attached to the body 402 proximal to the flap 360. The ring 404 includes cleaning surfaces in the form of surface 405 and edges 406. The body 402 may be solid, semisolid, or a balloon or other inflatable structure. While illustrated as smooth, the surfaces and edges of the cleaning device 400 may be textured, roughened, or include surface features to increase the cleaning efficiency.

The device is illustrated in FIGS. 18-24, in addition to other embodiments, illustrate cleaning devices where the cleaning device has a proximal end and a distal end and the proximal end has a circumference that nearly matches the circumference of the instrument and the distal end has a circumference larger than the instrument. Additionally, the various scrapers, edges and cleaning surfaces illustrated in the various embodiments provide numerous examples of cleaning surfaces that are non-continuous with other cleaning surfaces on the same cleaning device.

In an embodiment where the body is inflatable, the ring 404 and the portion of the flap 360 extending around the body 402 are expandable along with the inflatable body. The use of an inflatable cleaning device body 402 allows the cleaning device 400 to advance to the treatment site in a reduced diameter size (i.e., deflated). Once positioned at the treatment site, the body 402 is inflated in order to place the cleaning surfaces of the device 400 into contact with tissue at the treatment site.

In addition to using inflatable cleaning devices, other techniques are possible to reduce the diameter of the cleaning device for advancement to a treatment site. For example, FIG. 25 illustrates a cleaning device 350 (described above in FIG. 19A) in a stowed configuration within a sheath 399. The sheath 399 is positioned around at least a portion of the cleaning device. Inside of the sheath 399, the flaps 342 are held against the outer surface of the instrument 50 thereby reducing the overall diameter of the cleaning device. As such, cleaning device 350 illustrates an example of a cleaning device movable between a stowed condition adjacent the instrument and a deployed condition for engaging tissue on the lumen. Additionally, the cleaning device 350, along with other embodiments described herein, illustrate a cleaning device diameter in a stowed condition that is less than the diameter of the cleaning device in the deployed condition. In this way, a cleaning device may remain in a stowed condition during movement to a treatment site. Once positioned at the treatment site, the sheath 399 is withdrawn and the flaps 342 expand out into the open configuration illustrated in FIG. 19A. While described with reference to the cleaning device of FIG. 19A, a sheath may be used to reduce the diameter or render a stowed configuration to any cleaning device embodiment described herein.

FIG. 26A illustrates a cleaning device 420 within a cavity 72 in an instrument 50. The cleaning device 420 includes an expandable hoop or ring mounted on a shaft 418. In the illustrated embodiment, the hoop is open and when extended out of the cavity 72 will expand into contact with the surrounding tissue. Alternatively, the hoop may be closed loop with a fixed diameter selected for a particular treatment site. The cavity 72 may be a dedicated port in the instrument 50 for storing the cleaning device 420. The cavity 72 may also be the working channel of an endoscope. While the cavity 72 is illustrated in use with a hoop style cleaning device, is to be appreciated that either or both of the cavity and cleaning device may be modified to allow any cleaning device described herein to be deployed from a cavity or working channel of an instrument.

FIG. 26B illustrates the cleaning device of FIG. 26A in use to remove tissue. As illustrated, the cleaning device 420 has exited the cavity 72 and expanded into contact with the tissue at a treatment site 60. FIG. 26B also provides another example where in the diameter of the cleaning device in the stowed condition (FIG. 26A) is less than the diameter of the cleaning device in the deployed condition.

As used herein, and edge on a cleaning device may be a blunt edge. A blunt edge is an edge on a cleaning device or a cleaning surface having a shape, contour, texture or other form suited to the removal of debris by rubbing, scraping or abrasion. As such, a portion of a cleaning device may comprise a blunt edge. Moreover, the blunt edge may be supported by one or more of a frame, a ridge or a ring as illustrated and described herein. Generally, during typical use, a blunt edge as described herein will not lacerate tissue at a treatment site.

While the above description relates to the use of cleaning devices of the inventions during ablation treatments, the device and methods of the invention are not so limited. Other alternative uses of the cleaning devices are possible. For example, a cleaning device may be used to clean, wipe or otherwise remove debris such as, but not limited to, food, mucus, blood, or alimentary tract by-products such as bile, feces and the like from the alimentary tract. Removal of this debris may enhance visualization of the organ to aid in performing a diagnosis or evaluation. By removing debris as a result of using a cleaning device or method described herein, a physician or health care provider may be better able to determine the location of bleeding, evaluate or analyze tissue type, identify and/or localize a perforation or prepare an organ for a subsequent therapeutic or diagnostic treatment (e.g., biopsy, ablation, banding and the like).

Additionally, embodiments of the cleaning devices and methods described herein may be used to produce hemostasis of alimentary tract bleeds. Utilizing the devices and methods described herein for tamponade, it is believed that temporary or permanent hemostasis could be achieved. To assist in permanent hemostasis, the device may be coated with a material to assist in thrombosis such as thrombin, fibrin, collagen or other suitable coatings or pharmacological agents. Additionally or alternatively, the cleaning device may be formed from thrombin, fibrin or collagen or coated by partially or completely by these or similar materials. Additionally, the characteristics of the cleaning device such as the roughness, porosity, absorption qualities such as a hydrophilic material, material selection, and/or suitable conventional material pretreatment may be used to adapt the device for particular applications such as for cleaning, hemostatis or for other applications.

While numerous embodiments of the present invention have been shown and described herein, it is to be appreciated by those of skill in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitution will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby. 

1. A method of treating tissue requiring treatment in an alimentary tract, the method comprising: positioning a therapy system within the alimentary tract, the therapy system comprising an instrument including an ablation device positioned at a distal end and a cleaning device supported positioned adjacent to and proximal the ablation device; moving the ablation device to a treatment site in the alimentary tract; ablating tissue at the treatment site; moving the cleaning device to the treatment site while the ablation device remains in proximity of the treatment site; and contacting and cleaning tissue treated by the ablation device by moving the cleaning device relative to the treatment site for removing treated tissue to prepare the treatment site for a follow on treatment by the ablation device.
 2. The method of claim 1 wherein the cleaning comprises abrading a tissue surface at the treatment site.
 3. The method of claim 1 wherein the moving comprises rotating the instrument.
 4. The method of claim 3 wherein the moving comprises moving the instrument in a longitudinal direction.
 5. The method of claim 1 further comprising, after the cleaning, determining whether an additional treatment is needed at the treatment site.
 6. The method of claim 5 further comprising, after the determining, ablating the tissue at the treatment site.
 7. The method of claim 1 further comprising contacting the treatment site with the cleaning device to produce hemostasis of bleeding requiring treatment.
 8. The method of claim 7 wherein the cleaning device comprises a member selected from thrombin, fibrin, collagen, and combinations of the same.
 9. The method of claim 1 wherein the positioning comprises advancing the instrument through the mouth and into the esophagus. 